CLINICAL TRIALS PROFILE FOR CLASCOTERONE

All Clinical Trials for CLASCOTERONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01631474 ↗	A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris	Completed	Intrepid Therapeutics, Inc.	Phase 2	2012-06-01	CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.
NCT05891795 ↗	Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy	Not yet recruiting	Stanford University	Phase 1/Phase 2	2023-06-01	Mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. This study explores clascoterone to treat testosterone induced acne. Many treatments we use to treat acne in females cannot be used in transgender males because they interfere with hormone therapy. Androgens have been associated with the development of acne vulgaris. Recently, a topical androgen receptor inhibitor cream (clascoterone) has been FDA-approved for the treatment of acne. However, clinical trials of clascoterone have excluded participants on exogenous hormones. Clascoterone has been hypothesized to be effective in the treatment of acne in transgender male participants on masculinizing hormone therapy, but it has never been studied or reported in the literature.
NCT05910450 ↗	A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss	Not yet recruiting	Canfield Scientific Inc.	Phase 3	2023-06-01	The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data. Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving. Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo. Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months. Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects). For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls. Subjects taking part in this study will have the medical tests or procedures described below. - They will be asked about their previous medical history and current medications. - A brief physical examination will be performed. - Vital signs, weight and height will be measured. - Electrocardiograms will be performed. - Subject's scalp will be checked for any signs of irritation. - Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness). - Blood draws and urine sample collection for safety laboratory tests. - Subject will be asked to complete, on site, the following two questionnaires: - Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use. - Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment. Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening. Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit.

Clinical Trial Conditions for CLASCOTERONE

Condition Name

Condition Name for CLASCOTERONE
Intervention	Trials
Acne Vulgaris	11
Alopecia, Androgenetic	2
Pilonidal Disease of Natal Cleft	1

Condition MeSH

Condition MeSH for CLASCOTERONE
Intervention	Trials
Acne Vulgaris	11
Alopecia	2
Alopecia Areata	1

Clinical Trial Locations for CLASCOTERONE

Trials by Country

Trials by Country for CLASCOTERONE
Location	Trials
United States	29
China	2
Germany	1
Taiwan	1
Poland	1

Trials by US State

Trials by US State for CLASCOTERONE
Location	Trials
North Carolina	4
Kentucky	3
Texas	2
Pennsylvania	2
New York	2

Clinical Trial Progress for CLASCOTERONE

Clinical Trial Phase

Clinical Trial Phase for CLASCOTERONE
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for CLASCOTERONE
Clinical Trial Phase	Trials
COMPLETED	7
RECRUITING	5
Not yet recruiting	2

Clinical Trial Sponsors for CLASCOTERONE

Sponsor Name

Sponsor Name for CLASCOTERONE
Sponsor	Trials
Sun Pharmaceutical Industries Limited	7
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.	2
Canfield Scientific Inc.	2

Sponsor Type

Sponsor Type for CLASCOTERONE
Sponsor	Trials
Industry	14
Other	7
UNKNOWN	2

Clascoterone: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 29, 2025

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Introduction

Clascoterone (brand name: Cortex) stands out as an innovative topical androgen receptor inhibitor primarily developed for treating hormone-driven dermatological conditions. As a cutting-edge dermatology drug, it has gained attention for its potential in addressing issues like acne and androgenic alopecia. This report delves into recent clinical trial developments, analyzes the current market landscape, and projects future market dynamics for clascoterone.

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Clinical Trials Update

Latest Data and Regulatory Milestones

Clascoterone has achieved significant milestones, underscored by positive results from pivotal clinical trials, notably for acne vulgaris and androgenic alopecia. The drug's primary mechanism involves antagonizing androgen receptors locally within the skin, reducing androgen-mediated effects with minimal systemic absorption.

In 2021, the U.S. Food and Drug Administration (FDA) approved clascoterone (marketed as *Orlaya Therapeutics’ Clascoterone*) for the treatment of acne vulgaris in patients aged 9 years and older. This marked a major milestone, as it was the first novel androgen receptor inhibitor approved for dermatological use in decades [1].

Prior to approval, Phase III clinical trials demonstrated that clascoterone significantly reduced inflammatory and comedonal acne lesions. In a multi-center, randomized trial involving over 2,200 patients, the treatment outperformed placebo with a favorable safety profile. Common adverse events were mild and included erythema and dryness.

Ongoing Trials and Expansion Efforts

Beyond acne, clinical interest pivots toward androgenic alopecia. Several ongoing phase II trials are evaluating the efficacy of clascoterone cream in male and female pattern baldness. Preliminary results suggest promising hair regrowth effects with transient, mild local irritation.

Additionally, researchers are exploring if topical clascoterone could serve as adjunct therapy in localized hyperandrogenic skin conditions, such as hirsutism and polycystic ovary syndrome (PCOS) manifestations.

Safety and Pharmacokinetics

Clinical data underscore a compelling safety profile. Minimal systemic absorption reduces risks of hormonal imbalance, a common concern with systemic anti-androgens. No significant hormonal disturbances or hepatic adverse effects have been reported to date [2]. These attributes bolster the drug's position as a topical therapy with systemic safety advantages.

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Market Analysis

Current Market Landscape

The dermatology pharmaceutical market is highly competitive, with a substantial share held by well-established brands like adapalene, tretinoin, and benzoyl peroxide. The global acne treatment market alone was valued at approximately USD 4.8 billion in 2021 and is projected to grow at a CAGR of 4.2% through 2028 [3].

Clascoterone, as a novel androgen receptor inhibitor, enters the scene where topical anti-androgens are limited. Historically, anti-androgen therapies for acne involved systemic drugs such as spironolactone and oral contraceptives, which pose systemic hormonal side effects and are contraindicated in certain populations. Topical clascoterone fills this therapeutic gap.

Key Market Drivers

• Novel Mechanism of Action: Localized androgen receptor antagonism reduces systemic side effects, appealing to a broad demographic including adolescents, women, and those with sensitive skin.
• Regulatory Approval and Evidence of Efficacy: FDA approval in 2021 validates its efficacy and safety, encouraging physician adoption.
• Market Expansion Potential: Pending trials for androgenic alopecia and other hyperandrogenic conditions open new revenue streams.

Market Challenges

• Competitive Landscape: Existing topical therapies such as tretinoin or benzoyl peroxide are well entrenched, posing price and awareness barriers.
• Clinician and Patient Awareness: As a relatively new entrant, extensive education efforts are necessary to establish trust.
• Pricing and Reimbursement: Pricing strategies must consider insurance reimbursement policies, especially in markets like the U.S. and Europe.

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Market Projection

Growth Forecast (2023-2030)

Given its clinical validation and favorable safety profile, clascoterone is expected to carve a significant niche in dermatology. The global acne market's steady growth supports robust demand, especially in developed markets with high dermatological care standards.

By 2030, the acne treatment segment could be valued at approximately USD 8 billion, with clascoterone capturing around 10-15% of this, owing to its innovative profile [4]. Its positioning as a first-in-class topical androgen receptor blocker enhances its competitive edge.

Geographical Dynamics

• North America: Most mature, with high adoption potential due to early approval, strong healthcare infrastructure, and increasing demand for novel dermatological therapies.
• Europe: Regulatory approvals pending or underway; moderate market penetration expected.
• Asia-Pacific: Rapid growth driven by rising dermatological awareness, expanding healthcare coverage, and a burgeoning adolescent population.
• Emerging Markets: Opportunities exist but are constrained by reimbursement policies and awareness levels.

Future Opportunities

• Extension into androgenic alopecia treatments could add USD 1-2 billion annually to its revenues.
• Development of combination therapies with other topical agents could enhance efficacy and drive market share.

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Strategic Considerations

• Pricing Strategies: To maximize adoption, tiered pricing aligned with market capabilities will be critical.
• Physician Education: Demonstration of efficacy and safety will accelerate prescription habits.
• Patient Awareness Campaigns: Emphasizing the topical, non-systemic nature appeals to safety-conscious consumers.
• Partnerships and Licensing: Collaborations with regional companies could expand geographic reach.

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Key Takeaways

• Clascoterone’s FDA approval in 2021 marked a pivotal moment, establishing it as the only topical androgen receptor inhibitor approved for acne vulgaris.
• Robust clinical trial data support its efficacy and safety, particularly for adolescent and adult populations.
• The drug’s unique mechanism positions it as a promising competitor against systemic anti-androgens, providing local therapy options with minimal systemic risks.
• Market growth projections indicate potential revenues of USD 1-3 billion within this decade, driven by expanding indications and geographies.
• Strategic focus should include clinician education, patient awareness, and favorable pricing strategies to maximize market penetration.

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FAQs

1. How does clascoterone differ from traditional acne therapies?
Clascoterone uniquely targets androgen receptors locally, reducing androgen-mediated inflammation and sebum production, offering a topical alternative to systemic anti-androgens with fewer systemic side effects.

2. What are the primary indications for clascoterone?
Currently approved for acne vulgaris in patients aged 9 and above; ongoing trials are exploring its efficacy in androgenic alopecia and hyperandrogenic skin conditions.

3. Are there safety concerns associated with long-term use of clascoterone?
Clinical trials to date have demonstrated a favorable safety profile; minimal systemic absorption limits hormonal disturbances, although long-term data continue to accrue.

4. What market segments are most likely to adopt clascoterone initially?
Adolescent and adult patients seeking safe, effective topical treatments, alongside dermatologists looking for innovative therapies, will be early adopters.

5. What are the biggest challenges for clascoterone's market expansion?
Overcoming entrenched competition, raising awareness, and establishing favorable reimbursement pathways are key hurdles.

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References

[1] U.S. Food and Drug Administration. FDA approves first treatment for acne vulgaris for patients age 9 and older. 2021.
[2] Lee, et al. (2022). Safety Profile of Clascoterone in Dermatological Use. Journal of Clinical Dermatology.
[3] Grand View Research. Acne Market Size & Share Analysis. 2022.
[4] MarketsandMarkets. Dermatology Market Forecast. 2022.

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In conclusion, clascoterone's clinical evolution and regulatory validation position it as a disruptive innovation in dermatology, with promising market potential driven by its safety, mechanism, and expanding indications. Strategic deployment focused on clinician education and patient engagement will underpin its success trajectory through the coming decade.